The Effect of Foot Reflexology on Infantile Colic Symptoms
NCT ID: NCT03939611
Last Updated: 2019-05-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
45 participants
INTERVENTIONAL
2016-06-26
2017-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Method: The study was conducted as a single-blind, randomized, placebo-controlled trial in a child hospital between June 2016 and March 2017. To start with, 20 infants with colic were randomly selected for the reflexology group, and 25 babies with colic were randomly selected for the placebo group. Simple randomization was used; the parents and statistician were blinded to group assessment. The researcher could not be blinded because of the role played in the study. Foot reflexology was implemented with reflexology-group infants. Placebo foot reflexology was used with placebo-group infants. Both interventions were performed four times, for 20 minutes, each, by the researcher over the course of two weeks. The data were collected by the researcher using the information form, infantile colic scale, behavioral pain scale, crying and sleeping follow-up forms.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Physiotherapy and Osteopathy on Infant Colic
NCT03326297
Efficacy of a Craniosacral Therapy Protocol in the Treatment of Infant Colic
NCT03675763
The Effect of Therapeutic Touch on Colic Symptoms in Infantile Colic Infants: A Randomized Controlled Study
NCT04286737
Effect of Reflexology on Pain Management in Newborns
NCT05235893
Effects of Acupuncture in the Treatment of Infant Colic
NCT00907621
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Foot Reflexology Group
Foot reflexology was performed to the reflexology group infants. Foot reflexology application (FRA) involved relaxation for the first 3-5 minutes and the last 2 minutes; the remaining 12-15 minutes included stimulation of the brain and digestive system organs. To ensure relaxation, rotation was performed by using the thumbs of the hand under the feet, cephalocaudally. The session of FRA included stimulating the brain and medulla spinalis (2 min), the solar plexus (1min), the stomach (2min), the liver (2min), the pancreas (2min), the gallbladder (1min), and the ileocecal valve and intestine (5min) reflex points. Application was performed on all infants twice a week, for a total of four times during two consecutive weeks. Between two consecutive applications, a minimum of 48 hours and a maximum of 5 days was allotted (Stone, 2011). A total of 6 follow-ups were performed during the study period.
Foot Reflexology
Reflexology is one of the complementary health approaches; it is based on systematic pressure and stimulation with fingers to energy points in feet and hands and is a topic nowadays studied. Reflexology argues that the reflex maps in the hands and feet with all of the parts of the body are in contact. The pressure applied to each point stimulates the circulation of blood and energy like a sensor, gives a sense of relaxation, provides homeostasis. With a touch that is a different way of communication with children, is supported to create physical awareness via reflexology techniques, and is provided healthy nutrition of the stimulated tissue.
Placebo Foot Reflexology Group
Placebo foot reflexology was performed to the placebo group infants. Placebo foot reflexology application (PFRA) was constrained to ineffective touch without any stimulation and pressure. The aim of the PFRA was to create only a touch effect. It was applied by patted the foot by using the thumbs of the hand, for 20 minutes with the same rotation and to the same points as FRA. Application was performed on all infants twice a week, for a total of four times during two consecutive weeks. Between two consecutive applications, a minimum of 48 hours and a maximum of 5 days was allotted (Stone, 2011). A total of 6 follow-ups were performed during the study period.
Placebo Foot Reflexology
Placebo reflexology was performed by touch without pressure to the same rotation and to the same points as foot reflexology application. It was performed only to compare foot reflexology with a placebo effect.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Foot Reflexology
Reflexology is one of the complementary health approaches; it is based on systematic pressure and stimulation with fingers to energy points in feet and hands and is a topic nowadays studied. Reflexology argues that the reflex maps in the hands and feet with all of the parts of the body are in contact. The pressure applied to each point stimulates the circulation of blood and energy like a sensor, gives a sense of relaxation, provides homeostasis. With a touch that is a different way of communication with children, is supported to create physical awareness via reflexology techniques, and is provided healthy nutrition of the stimulated tissue.
Placebo Foot Reflexology
Placebo reflexology was performed by touch without pressure to the same rotation and to the same points as foot reflexology application. It was performed only to compare foot reflexology with a placebo effect.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
1 Month
3 Months
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Akdeniz University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
NIMET KARATAS
Research Assistant
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ayşegül İŞLER DALGIÇ, Professor
Role: PRINCIPAL_INVESTIGATOR
Corresponding Author
References
Explore related publications, articles, or registry entries linked to this study.
Alexandrovich I, Rakovitskaya O, Kolmo E, Sidorova T, Shushunov S. The effect of fennel (Foeniculum Vulgare) seed oil emulsion in infantile colic: a randomized, placebo-controlled study. Altern Ther Health Med. 2003 Jul-Aug;9(4):58-61.
Bennedbaek O, Viktor J, Carlsen KS, Roed H, Vinding H, Lundbye-Christensen S. [Infants with colic. A heterogenous group possible to cure? Treatment by pediatric consultation followed by a study of the effect of zone therapy on incurable colic]. Ugeskr Laeger. 2001 Jul 2;163(27):3773-8. Danish.
Cetinkaya B, Basbakkal Z. A validity and reliability study investigating the Turkish version of the Infant Colic Scale. Gastroenterol Nurs. 2007 Mar-Apr;30(2):84-90; discussion 90. doi: 10.1097/01.SGA.0000267925.31803.30.
Chandrababu R, Rathinasamy EL, Suresh C, Ramesh J. Effectiveness of reflexology on anxiety of patients undergoing cardiovascular interventional procedures: A systematic review and meta-analysis of randomized controlled trials. J Adv Nurs. 2019 Jan;75(1):43-53. doi: 10.1111/jan.13822. Epub 2018 Sep 5.
Cirgin Ellett ML, Murphy D, Stroud L, Shelton RA, Sullivan A, Ellett SG, Ellett LD. Development and psychometric testing of the infant colic scale. Gastroenterol Nurs. 2003 May-Jun;26(3):96-103. doi: 10.1097/00001610-200305000-00002.
Embong NH, Soh YC, Ming LC, Wong TW. Revisiting reflexology: Concept, evidence, current practice, and practitioner training. J Tradit Complement Med. 2015 Sep 28;5(4):197-206. doi: 10.1016/j.jtcme.2015.08.008. eCollection 2015 Oct.
Cohen Engler A, Hadash A, Shehadeh N, Pillar G. Breastfeeding may improve nocturnal sleep and reduce infantile colic: potential role of breast milk melatonin. Eur J Pediatr. 2012 Apr;171(4):729-32. doi: 10.1007/s00431-011-1659-3. Epub 2011 Dec 29.
Helseth S. Help in times of crying: nurses' approach to parents with colicky infants. J Adv Nurs. 2002 Nov;40(3):267-74. doi: 10.1046/j.1365-2648.2002.02368.x.
Icke S, Genc R. Effect of Reflexology on Infantile Colic. J Altern Complement Med. 2018 Jun;24(6):584-588. doi: 10.1089/acm.2017.0315. Epub 2018 Apr 20.
Johnson JD, Cocker K, Chang E. Infantile Colic: Recognition and Treatment. Am Fam Physician. 2015 Oct 1;92(7):577-82.
Koc T, Gozen D. The Effect of Foot Reflexology on Acute Pain in Infants: A Randomized Controlled Trial. Worldviews Evid Based Nurs. 2015 Oct;12(5):289-96. doi: 10.1111/wvn.12099. Epub 2015 Jul 28.
Landgren K, Hallstrom I. Parents' experience of living with a baby with infantile colic--a phenomenological hermeneutic study. Scand J Caring Sci. 2011 Jun;25(2):317-24. doi: 10.1111/j.1471-6712.2010.00829.x. Epub 2010 Aug 18.
Reinthal M, Lund I, Ullman D, Lundeberg T. Gastrointestinal symptoms of infantile colic and their change after light needling of acupuncture: a case series study of 913 infants. Chin Med. 2011 Aug 11;6:28. doi: 10.1186/1749-8546-6-28.
Savino F, Ceratto S, De Marco A, Cordero di Montezemolo L. Looking for new treatments of Infantile Colic. Ital J Pediatr. 2014 Jun 5;40:53. doi: 10.1186/1824-7288-40-53.
Savino F, Quartieri A, De Marco A, Garro M, Amaretti A, Raimondi S, Simone M, Rossi M. Comparison of formula-fed infants with and without colic revealed significant differences in total bacteria, Enterobacteriaceae and faecal ammonia. Acta Paediatr. 2017 Apr;106(4):573-578. doi: 10.1111/apa.13642. Epub 2016 Nov 15.
Merkel SI, Voepel-Lewis T, Shayevitz JR, Malviya S. The FLACC: a behavioral scale for scoring postoperative pain in young children. Pediatr Nurs. 1997 May-Jun;23(3):293-7.
WESSEL MA, COBB JC, JACKSON EB, HARRIS GS Jr, DETWILER AC. Paroxysmal fussing in infancy, sometimes called colic. Pediatrics. 1954 Nov;14(5):421-35. No abstract available.
Zeevenhooven J, Browne PD, L'Hoir MP, de Weerth C, Benninga MA. Infant colic: mechanisms and management. Nat Rev Gastroenterol Hepatol. 2018 Aug;15(8):479-496. doi: 10.1038/s41575-018-0008-7.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
AkdenizUniversity
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.